Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)

Relapsing-remitting Multiple Sclerosis Clinical Trial

Official title:

Long-term Follow up of Patients With Relapsing-remitting Multiple Sclerosis Enrolled in the Multicenter, Single-arm, Open-label Biobank Study (CFTY720DDE01), to Investigate Changes in Biomarkers After 48 Months of Treatment With 0.5 mg Fingolimod (FTY720)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720107
• Other study ID #: CFTY720DDE01E1
• Status: Completed
• Phase: Phase 4
• Start date: May 12, 2016
• Est. completion date: November 14, 2016

Study information

• Verified date: September 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this single visit extension study is to explore immune status in RRMS patients treated for at least 48 months with fingolimod. Long-term changes in T cell counts will be compared to short-term changes in immune status (baseline to month 6) after treatment start with fingolimod as assessed in the original Biobank study (CFTY720DDE01).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: November 14, 2016
• Est. primary completion date: November 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent before any assessment was performed.

2. Randomized in study CFTY720DDE01 and received at least one dose of study drug (fingolimod) and completed the study.

3. Continuous intake of fingolimod after end of study CFTY720DDE01 with a maximum treatment interruption of 3 months in total before entering this study.

4. Parallel participation at study CFTY720DDE02 (Pangaea NIS) was allowed.

Exclusion criteriat:

1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test.

2. Patients with onset of an acute relapse had to postpone their evaluation until deemed stable from relapse by treating physician, but at least for 1 month since end of relapse.

3. Patients that received immunomodulating or immunosuppressive MS treatments other than fingolimod since completion of study CFTY720DDE01 as for example: Natalizumab,Alemtuzumab, Dimethyl fumarate, Teriflunomide, intravenous Immunoglobulins,Mitoxantrone, Methotrexate, Azathioprine or experimental immunomodulating-immunosuppressive therapies.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• fingolimod

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Altenholz-Stift
Germany	Novartis Investigative Site	Aschaffenburg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Boblingen
Germany	Novartis Investigative Site	Celle
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Erbach
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Göttingen
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Klingenmünster
Germany	Novartis Investigative Site	Lappersdorf
Germany	Novartis Investigative Site	Leverkusen
Germany	Novartis Investigative Site	Mönchengladbach
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Neuburg an der Donau
Germany	Novartis Investigative Site	Ostfildern	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Singen
Germany	Novartis Investigative Site	Troisdorf
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Unterhaching

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in T Cells Status (Decrease or Increase) at Month 48 (FAS)	Aim of trial was to was to show reduction of CD4+ and CD8+ naïve T cells (CCR7+CD45RA+), central memory T cells (CCR7+CD45RA-), central memory Th17 cells (CD4+ CCR4+ and CCR6+), and an elevation of 2 types of effector memory T cells TEM (CCR7- CD45RA-) and TEMRA (CCR7- CD45RA+) in peripheral venous blood. Changes from baseline to month 48 in biomarkers were analyzed for all patients in the FAS.	Baseline up to approximately 48 months
Secondary	Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS)	EDSS is a scale for assessing neurologic impairment in MS. It is a two-part system including; (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The definition of disability progression was based on increases in EDSS from baseline and depended on the EDSS baseline value: Disability progression was defined as a 1.5 increase in EDSS from baseline in subjects with a baseline EDSS score between 0.0 and 0.5, as a 1.0 increase in EDSS from baseline in subjects with a baseline EDSS score between 1.0 and 5.0 inclusive and 0.5 increase from baseline in subjects with EDSS score > 5.0.	Baseline up to approximately 48 months
Secondary	Change From Baseline in Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at Month 6 and Month 48 (FAS)	EDSS is a scale for assessing neurologic impairment in MS. It is a two-part system including; (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The definition of disability progression was based on increases in EDSS from baseline and depended on the EDSS baseline value: Disability progression was defined as a 1.5 increase in EDSS from baseline in subjects with a baseline EDSS score between 0.0 and 0.5, as a 1.0 increase in EDSS from baseline in subjects with a baseline EDSS score between 1.0 and 5.0 inclusive and 0.5 increase from baseline in subjects with EDSS score > 5.0.	Baseline, month 6 up to approximately 48 months
Secondary	Change in Immune Status of B Cells, Monocytes and Natural Killer Cells (NK) Cells (FAS)	Changes in immune status of B cells (CD19+, CD20+, CD69+), monocytes (CD14+) and NK cells (CD56+) were analyzed as a percentage of parent cell population (CD4+, CD8+ or total lymphocytes) by flow cytometry	Baseline up to approximately 48 months